Recall Z-1251-2025 ยท QPB System, Suction, Lipoplasty For Removal
HUMAN MED AG
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
| Date | Feb 28, 2025 (initiated Oct 18, 2024) |
| Status | Open, Classified |
| Reason | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet. |
| Root cause | Process control |
| Action | The recalling firm issued a Field Safety Notice to Distributors dated 10/18/2025 via email explaining the reason for the Field Safety Notice, the potential hazard, and informing the consignee to discontinue delivering the affected products to customers and users and to dispose of the product if still in their warehouse. A Field Safety Notice was enclosed to be issued to the consignee's users and customers who received the affected product from the Distributor. The User and Customer letter dated 10/17/2024 was similar to the Distributor letter except provided instructions to check the spray |
| Quantity | 775 devices |
| Distribution | US Nationwide distribution in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082025 | BODY-JET Human Med AG, Aug 13, 2008 |